Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Biosensors International Pte. Ltd..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 134 08 13 000
  • Event Initiated Date
    2013-08-19
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=4229
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
  • Extra notes in the data
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    In specific production lots of the affected device, biosensors has received reports of hub cracking prior to or during pci procedures. if not identified prior to use, the hub cracking may potentially lead to treatment delays or complications, which could cause a serious deterioration in the patient's state of health. as a result biosensors has initiated a voluntary recall of the affected devices. this issue is related exclusively to the delivery system hub. patients who have already been successfully implanted with an affected device are not impacted by this action.

Device

Drug-eluting coronary artery stent, BioMatrix NeoFlex

Manufacturer

Biosensors International Pte. Ltd.